Flash Glucose Monitoring System- Sensor - India CDSCO Medical Device Registration

Flash Glucose Monitoring System- Sensor is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000591_9e0864c7218e6e58008d44c47c9110a2_dfc951a33873afd90cd9252a8fe053ba. This device is marketed under the brand name FreeStyle Libre. The license holder is Abbott Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Flash Glucose Monitoring System- Sensor

UID: IMP/MD/2022/000591_9e0864c7218e6e58008d44c47c9110a2_dfc951a33873afd90cd9252a8fe053ba

Brand Name

FreeStyle Libre

License Holder

Abbott Healthcare Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The FreeStyle Libre Flash Glucose Monitoring System Sensor (FreeStyle Libre) when used with a compatible device is indicated for measuring interstitial fluid glucose levels in people(FreeStyle Libre) with diabetes mellitus, including pregnant women. The Sensor and compatible device are designed to replace blood glucose testing in the self-management of diabetes, including dosing of insulin. The indication for children (FreeStyle Libre) is limited to those who are supervised by a caregiver who is at least 18 years of age. The caregiver is responsible for managing or assisting the child to manage the sensor and compatible device and also for interpreting or assisting the child to interpret Sensor glucose readings.